Vicore Pharma Holding AB was granted a U.S. FDA breakthrough device designation for Almee, a cognitive behavioral therapy (CBT) software, to be used as an adjunct treatment by patients with anxiety symptoms due to pulmonary fibrosis. Vicore developed the nine-week CBT digital therapy in partnership with Alex Therapeutics AB. Read More
Surgeon, CEO and founder of Hutom Corp., Woo Jin Hyung, is working to level the playing field in the operating room with artificial intelligence (AI) and big data, leveraging digital technology to optimize surgical outcomes. Read More
Laboratory Corporation of America Holdings expanded its blood biomarker test portfolio for Alzheimer’s disease, making its pTau217 test available by prescription in the U.S. as well as for research globally. The standalone test can also be used in monitoring patients undergoing treatment for the neurodegenerative disease. Read More
Scottsdale, Ariz.-based Renovacare Inc., has come to terms over allegations that the company engaged in what the Securities and Exchange Commission (SEC) said was a pump-and-dump scheme designed to defraud the company’s investors. The initial SEC complaint dated May 28, 2021, alleges that Renovacare and company executives began making misleading statements to investors as far back as July 2017, making this yet another cautionary tale of duplicitousness in life science startups. Read More
The U.S. FDA has followed up on reports of problematic syringes made by several companies in mainland China, recommending that U.S. suppliers, consumers and health care organizations stop using these products unless no alternatives are available. The agency said it has issued warning letters to three of these companies, at least one of which appears to have been the supplier of Monoject syringes that have been the subjects of recent FDA recalls. Read More
In what represents its first patenting, Pittsburgh-based Reach Neuro Inc. is seeking protection for methods, sensors, and systems for detecting movement of a spine and stimulating specific regions of the spinal cord in response to the movement. Read More
New hires and promotions in the med-tech industry, including: Insulet, Gynesonics, Now Diagnostics, Seek Labs, Smartcardia, Vista.ai, Volition Rx. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bayer, Infutronix, Livanova, Proverum, Thermo Fisher. Read More
